CPDA-1 by is a Prescription medication manufactured, distributed, or labeled by Fenwal, Inc., Fenwal International, Inc.. Drug facts, warnings, and ingredients follow.
Sólamente Rx
Antes de continuar, identifique la unidad BOLSANG™ utilizando el sistema de identificación de donante adecuado.
NOTAS:
PRECAUCIONES A TOMARSE
Superficie interior estéril y libre de pirógenos. Esterilización por vapor. Utilice sólo una vez. No ventilar. Deseche el envase según corresponda.
Almacenar a temperatura ambiente controlada.
Farmacopea de los Estados Unidos. “Avisos Generales” United States
Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD
Rx only
Before proceeding further, identify BLOOD-PACK™ unit using appropriate donor identification system.
NOTES:
CAUTIONS TO BE TAKEN
Sterile, non-pyrogenic fluid path. Steam sterilized.
Single use only. Do not vent.
Dispose of container appropriately.
Store at Controlled Room Temperature. USP Definition of “Controlled Room Temperature” United States Pharmacopeia, General Notices.
United States Pharmacopeial Convention, Inc.
12601 Twinbrook Parkway, Rockville, MD
– Fabricante/Manufacturer
Fabricado por/Manufactured by:
Fenwal International, Inc.
Road 357, Km. 0.8
Maricao, PR 00606
Hecho en EE. UU. / Made in USA
Importado y distribuido en India por:/
Imported and distributed in India by:
Fenwal India Pvt Ltd
Upper Ground Floor, Tower B
DLF Building No. 10, DLF Cyber City
DLF Phase II, Gurgaon 122 002,
Haryana, India
Import License No.: FF-504-14890
Importado y distribuido en Indonesia por:/
Imported and distributed in Indonesia by:
PT. Medquest Jaya Global
Menara Salemba 6th Floor
Jl.Salemba Raya Kav 5-5A
Jakarta-Indonesia 10440
Importado y distribuido en Thailand por:/
Imported and distributed in Thailand by:
Fenwal (Thailand) Ltd.
17th Fl. Thanapoom Tower
1550 New Petchburi Rd., Makasan
Rajthevi, Bangkok 10400
Thailand
Reg. No.:
Importado y distribuido en Perú por:/
Imported and distributed in Perú by:
HERSIL S.A. LABORATORIOS INDUSTRIALES FARMACÉUTICOS
Av. Los Frutales No. 220
Ate, Lima 3 –Perú
RUC: 20100060150
Q.F. Responsable: Antonio Benitez Z.
Reg. No.:
Importado y distribuido en Venezuela por:/
Imported and distributed in Venezuela by:
SOLUCARE GT, C.A. RIF J-30512494-9
en La Urbina, Caracas,
Republica Bolivariana de Venezuela
TELF (0212) 2436663
Representante legal: Ynecel C. Obando M.MSAS 5635
Importado y distribuido en Colombia por:/
Imported and distributed in Colombia by:
Fenwal Colombia Ltda.
Centroempresa, Cali, Colombia
Reg. No.: INVIMA-2006M-0000140-R1
07-19-04-282 REV: A 01/2010
FENWAL, BOLSANG, ADSOL, OPTIPRESS y OPTIPAC son Marcas Registradas de Fenwal, Inc.
FENWAL, BLOOD-PACK, ADSOL, OPTIPRESS and OPTIPAC are trademarks of Fenwal, Inc.
DONORCARE is a trademark of ITL Corporation.
DONORCARE es una marca comercial de ITL Corporación.
© 2010 Fenwal, Inc. Todos los derechos reservados. All rights reserved.
REF R4R7292
8 Units
Fenwal™
Double Blood-Pack™ Unit Anticoagulant Citrate Phosphate Dextrose Adenine Solution (CPDA-1)
PL 146 Plastic
Rx only
Double Blood-Pack unit consisting of a primary pack containing 49 mL of CPDA-1 anticoagulant solution and one transfer pack without solution for collection of 350 mL of blood, 16 gauge needle.
See instructions for use. Sterile, non-pyrogenic fluid path. Steam sterilized. Single use only. Do not vent. Do not use if there is any visible evidence of deterioration. Dispose of container appropriately. Store at Controlled Room Temperature (refer to direction insert).
Unused packs in open foil pouch may be kept to 60 days by folding and securing open end of foil pouch, to prevent possible loss of moisture. Direct handling of product surfaces prior to extended storage in the foil pack may result in mold growth.
CPDA-1 formula: Each 49 mL CPDA-1 solution contains 1.56 g Dextrose (monohydrate), USP, 1.29 g Sodium Citrate (dihydrate), USP, 160 mg Citric Acid (monohydrate), USP , 109 mg Monobasic Sodium Phosphate (monohydrate), USP, 13.5 mg Adenine, USP, Water for Injection USP to 49 mL.
Manufactured by:
Fenwal International, Inc.
Road 357, Km. 0.8
Maricao, PR 00606
Made in USA
07-28-03-950 REV: A
Imported and distributed in India by:
Fenwal India Pvt Ltd
Upper Ground Floor, Tower B
DLF Building No. 10, DLF
Cyber City, DLF Phase-II, Gurgaon 122 002,
Haryana, India
Import License No.: FF-504-14890
MRP Rs.: 146 (Inclusive of all taxes)
FENWAL and BLOOD-PACK are trademarks of Fenwal, Inc.
CPDA-1
anticoagulant citrate phosphate dextrose adenine solution |
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Labeler - Fenwal, Inc. (794519020) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Fenwal International, Inc. | 091164590 | MANUFACTURE(0942-6328) |